ANDA 077652

ZYDUS PHARMS USA INC

FDA Drug Application

Application #077652

Application Sponsors

ANDA 077652

ZYDUS PHARMS USA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	250MG	0	LEVOFLOXACIN	LEVOFLOXACIN
002	TABLET;ORAL	500MG	0	LEVOFLOXACIN	LEVOFLOXACIN
003	TABLET;ORAL	750MG	0	LEVOFLOXACIN	LEVOFLOXACIN

FDA Submissions

	ORIG	1	AP	2012-09-07
LABELING; Labeling	SUPPL	2	AP	2014-09-25	STANDARD
LABELING; Labeling	SUPPL	3	AP	2014-09-25	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	10	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	15	AP	2019-04-16	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-05-03	STANDARD
LABELING; Labeling	SUPPL	17	AP	2020-05-29	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2022-04-04	UNKNOWN

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	8	Null	15
SUPPL	10	Null	15
SUPPL	14	Null	15
SUPPL	15	Null	7
SUPPL	16	Null	7
SUPPL	17	Null	15
SUPPL	19	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

ZYDUS PHARMS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77652
            [companyName] => ZYDUS PHARMS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"750MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LEVOFLOXACIN","submission":"LEVOFLOXACIN","actionType":"750MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)